Genomic Health, Inc. (Nasdaq: GHDX) today announced results of six studies being presented at the 2014 American Society of Clinical Oncology ASCO Annual Meeting taking place May 30 – June 3 in Chicago, underscoring the practice-changing value of Oncotype DX in pre-invasive and invasive breast cancer and colon cancer.
The presentations include the first Oncotype DX DCIS Score clinical decision impact study, which showed a 31 percent change in treatment recommendations. Additionally, a direct comparison study of the Oncotype DX breast cancer test and the ROR score confirmed that the assays are not the same and that the information they provide is not equivalent.

Oncotype DX DCIS Score Changes Treatment Recommendations for One Out of Three Patients with Pre-Invasive Breast Cancer (Abstract #11050)

Ductal carcinoma in situ (DCIS), also referred to as stage 0 breast cancer, affects one out of every five women diagnosed with breast cancer in the United States and is often treated with surgery followed by radiation therapy and/or hormonal therapy. With only 20 percent of cases estimated to recur or turn into invasive breast cancer, it is estimated that about 40,000 women each year receive additional treatments that may not be needed.

“Currently, most DCIS patients are treated with surgery followed by radiation, despite the fact that no treatment beyond surgery has been shown to impact long-term survival,” said Michael Alvarado, M.D., associate professor of surgery, the University of California, San Francisco (UCSF). “These results highlight the huge need in optimizing treatment of this non-invasive, indolent form of breast disease, and the importance of the Oncotype DX DCIS Score to help physicians reduce over- and under-treatment of DCIS.”

A comparison study in collaboration with UCSF, Marin Medical Laboratories in California, and investigators from the Athens University Medical School in Greece evaluated if the information provided by Oncotype DX and the ROR scores are equivalent. Specifically, results in 52 node-negative, post-menopausal patients revealed a very low concordance between Oncotype DX and ROR results, (correlation = 0.08, 95% CI -0.19, 0.35) highlighting the potential to misclassify patients if other assays are used to make a decision regarding chemotherapy treatment. The high level of discordance between the Oncotype DX Recurrence Score and ROR results seen in this study provides additional evidence to support the findings from an independent, previously conducted 1,017-patient comparison study published in the Journal of Clinical Oncology, which showed that Oncotype DX Recurrence Score and ROR classified patients differently (correlation = 0.39) (Dowsett et al, JCO 2013).

“If the question is whether or not to use chemotherapy, Oncotype DX is the only test that has been appropriately studied and validated to answer the specific question of which invasive breast cancer patients need chemotherapy, and all multi-gene tests are not the same,” said Lee S. Schwartzberg, M.D., chief, Division of Hematology Oncology, The University of Tennessee Health Science Center.